A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01410747
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.

Detailed Description

The objectives of the survey are to evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use situations, and to identify factors that might affect the safety and efficacy of tacrolimus. In addition, long-term renal outcome will be evaluated.

Study Timeline

• Study Start: 2007-04-10
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-03
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1484

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tacrolimus group	Tacrolimus	Oral

Primary Outcome Measures

Name	Time	Method
Incidence of renal events (renal failure and progression to dialysis)	Up to 10 years

Secondary Outcome Measures

Name	Time	Method
24-hour urinary protein	Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year
Urinary red blood cell (RBC) count	Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year
Serum creatinine	Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year